Multitarget Strategy for Primary Podocytopathies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2032-11-30

Brief Summary

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The goal of this clinical trial is to verify whether a cell culture system can be used to evaluate the presence of a factor capable of causing proteinuria in the serum of patients with primary podocytopathies. This system will also be used to evaluate the in vitro efficacy of a combined therapy for the treatment of this disorder.

Researchers will compare samples from patients with primary podocytopathies with those obtained from healthy subjects and patients with other renal disorders.

Participants will be asked to visit the clinic at regular intervals for up to 36 months, and to provide blood and urine samples (and a sample of the discarded plasmapheresis effluent in case the procedure is performed).

Detailed Description

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Conditions

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Nephrotic Syndrome

Keywords

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podocytopathy transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Biologic fluid sampling

The only interventions in addition to standard clinical practice will be blood sampling, the collection of morning spot urine and the collection of the discarded effluent of the plasmapheresis procedure (when performed according to clinical indication).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Signature of informed consent for study participation
* One of the following conditions:

1. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) showing clinical and/or histological evidence of post-transplant recurrence.
2. Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) without clinical and/or histological evidence of post-transplant recurrence.
3. Patients with primary podocytopathies in their native kidneys in an active clinical phase of the disease.
4. Patients with podocytopathies presenting clinical features compatible with a secondary form due to another condition.
5. Patients with glomerulonephritis other than primary podocytopathies (e.g., IgA nephropathy, systemic lupus erythematosus, membranous nephropathy).
6. Patients with no history of renal diseases

Exclusion Criteria

* Subjects affected by primary podocytopathies or other glomerulonephritides in clinical remission or with ESRD (eGFR \< 15 ml/min) and/or on renal replacement therapy
* Individuals unable to understand and consent to the study procedures
* Any clinical condition that, according to the investigator's judgment, could compromise patient safety during study participation

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Countries

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Italy

Central Contacts

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Manuel A Podesta', MD, PhD

Role: CONTACT

Phone: 0039 0255034568

Email: [email protected]

Giuseppe Castellano, MD, PhD